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medicine: agomelatine
agomelatine description
Agomelatine (trade names Valdoxan, Melitor, Thymanax) is an antidepressant developed by the pharmaceutical company Servier. It is classified as a norepinephrine-dopamine disinhibitor (NDDI) due to its antagonism of the 5-HT2C receptor. Activation of 5-HT2C receptors by serotonin inhibits dopamine and norepinephrine release. Antagonism of 5-HT2C results in an enhancement of DA and NE release and activity of frontocortical dopaminergic and adrenergic pathways. Agomelatine is also a potent agonist at melatonin receptors which makes it the first melatonergic antidepressant. Because of its unique profile, agomelatine has not been associated with weight gain, sexual side effects, sleep problems or withdrawal syndrome; this is in contrast to most SSRIs and many antidepressants.
Studies
Although some controlled studies in humans have shown that agomelatine is as effective as the SSRI antidepressants paroxetine and sertraline in the treatment of major depression, three unpublished randomised controlled trials have failed to show that agomelatine is any more effective than placebo tablets. Indeed, five of the six trials comparing agomelatine with placebo have shown that the drug is no more likely than placebo to induce remission from major depression. Agomelatine appears to cause fewer sexual side effects and discontinuation effects than sertraline and paroxetine. Additionally, possibly because of its action on melatonin receptors, agomelatine appears to improve sleep quality, with no reported daytime drowsiness. Agomelatine has demonstrated anxiolytic properties, although its efficacy in anxiety disorders has not been tested.
Development
Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd. Servier continued to develop the drug and conduct phase III trials in the European Union. In March 2005 Servier submitted agomelatine to the European Medicines Agency (EMEA) under the trade names Valdoxan and Thymanax. On 27 July 2006 the Committee for Medical Products for Human Use (CHMP) of the EMEA recommended a refusal of the marketing authorisation of Valdoxan/Thymanax (agomelatine). The major concern was that efficacy had not been sufficiently shown. The CHMP had no special concerns about the side effects. In September 2007, Servier submitted a new marketing application for Valdoxan (agomelatine) to the EMEA. On 20 November 2008, Valdoxan was given a positive opinion, with restrictions, by the EMEA, and was subsequently given marketing authorisation in the European Union on 20 February 2009. Release dates for agomelatine will depend on marketing arrangements in the individual countries of the EU.
In March 2006, Servier announced it had sold the rights to market agomelatine in the United States to Novartis. Agomelatine is currently undergoing phase III clinical trials in the US.
Novartis currently lists the drug as scheduled for submission to the FDA no earlier than 2012.
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